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Is the risk of GMP dis-harmonisation in the field of ATMPs (Advanced Therapy Medicinal Products) real?

  • 12 мая 2017
  • ATMP, CTA, GMP, IMP, MAH, PIC/S, высокотехнологичные лекарственные средства, лекарственные препараты для клинических исследований, НПП,

ASE Pharma Solutions

The PIC/S Committee, which comprises representatives of PIC/S’ 49 Participating Authorities as well as representatives from Partner Organisations such as EMA, EDQM and WHO, expressed its unanimous concern at the European Commission’s proposed stand-alone Advanced Therapy Medicinal Products (ATMP) GMP Guidelines, which will not only lower GMP standards for ATMP at the risk of patients but lead to an internationally non harmonised approach to the implementation of GMP for ATMP. The Committee has discussed the matter at its last meeting in Geneva on 9-10 February 2017.

We have already informed on our website about the draft Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products published by the European Commission (EC).

This initiative by the European Commission in the field of ATMP, which will lead to a revision of EU GMP Guide Annex 2 (Biological Products), will also result in the PIC/S GMP Guide and the EU GMP Guide no longer being equivalent. Since 1989, both Guides have been developed in parallel and systematically kept aligned on the basis of a harmonised consultation procedure between PIC/S and the European Medicines Agency (EMA).

It is also perceived that the lack of international harmonisation will potentially impact in the availability of ATMP across regions regulated by PIC/S Participating Authorities as well as cause regulatory burden for manufacturers which will have to comply with different codes, of which one will be of lower standards.

PIC/S has repeatedly tried to draw attention on the detrimental effects of this initiative but such efforts have so far proved fruitless.

More recently however, European Commission (EC) expressed its proposal for engagement with PIC/S on this initiative as well as the intent to ensure the quality of ATMPs and the protection of patient safety.

All details you will find in the open letters: PS L 11 2017 Letter to EC concerning GMP ATMP and PS L 20 2017 Letter to EC concerning GMP ATMP.